Label: CLEARASIL RAPIDLY CLEAR ACNE SOLUTIONS- salicylic acid kit

  • NDC Code(s): 63824-431-90, 63824-432-01, 63824-449-10
  • Packager: RB Health (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 17, 2023

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  • SPL UNCLASSIFIED SECTION

    Clearasil ®Rapid Rescue Deep Treatment Wash

    Drug Facts

  • Active ingredient

    Salicylic acid 2%

  • Purpose

    Acne medication

  • Use

    for the treatment of acne

  • Warnings

    For external use only

    When using this product

    • avoid contact with the eyes. If product gets into the eyes, rinse thoroughly with water.
    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
    • limit use to the face and neck

    Stop use and ask a doctor ifskin or eye irritation develops

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • wet face
    • dispense product into hands, lather and massage gently onto face and neck, avoiding the delicate eye area
    • rinse thoroughly with warm water and pat dry
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • Other information

    • store in a cool, dry place
    • do not freeze
  • Inactive ingredients

    water, sodium cocoyl isethionate, cetearyl alcohol, glycerin, sodium laureth sulfate, sodium cocoamphoacetate, cocamidopropyl betaine, sodium hydroxide, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, disodium EDTA, lavandula stoechas extract, helichrysum italicum extract, cistus monspeliensis extract

  • Questions?

    1-866-25-CLEAR (1-866-252-5327).

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Clearasil ®Rapid Rescue Deep Treatment Pads

    Drug Facts

  • Active ingredient

    Salicylic acid 2%

  • Purpose

    Acne medication

  • Use

    for the treatment of acne

  • Warnings

    For external use only

    Flammable,keep away from extreme heat or open flame

    When using this product

    • avoid contact with the eyes. If product gets into the eyes, rinse thoroughly with water.
    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
    • limit use to the face and neck

    Stop use and ask a doctor ifskin or eye irritation develops

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • clean the skin thoroughly before applying this product
    • wipe a pad over face and neck to cover the entire affected area with a thin layer one to three times daily
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • Other information

    • do not flush in toilet
    • keep jar lid tightly closed
    • store in a cool dry place but do not freeze
  • Inactive ingredients

    water, alcohol denat., glycerin, isoceteth-20, hydrogenated starch hydrolysate, sodium hydroxide, fragrance, lavandula stoechas extract, helichrysum italicum extract, cistus monspeliensis extract, disodium EDTA

  • Questions?

    1-866-25-CLEAR (1-866-252-5327).

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Distributed by: RB Health (US)
    Parsippany, NJ 07054-0224
    Wash and Pads Made in Brazil

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    Clearasil ®

    LESS ACNE.
    MORE SAVINGS!

    RAPIDLY CLEAR ACNE SOLUTIONS

    TREAT BREAKOUTS FAST

    VISIBILE
    RESULTS
    AS FAST AS
    12
    HOURS

    WASH
    ACNE PADS

    +

    HEAL ACNE SPOTS

    REDUCES
    RISK OF
    SCARRING

    SPOT PATCHES

    DEEP TREATMENT WASH
    SALICYLIC ACID ACNE TREATMENT
    6.78 FL OZ
    (200 ML)

    DEEP TREATMENT PADS
    SALICYLIC ACID ACNE TREATMENT
    90 PADS 2.19 IN
    (5.56 CM) DIA

    OVERNIGHT SPOT PATCHES
    18
    PATCHES
    SEE SIDE OF PACK FOR SIZE

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    CLEARASIL RAPIDLY CLEAR ACNE SOLUTIONS 
    salicylic acid kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-449
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-449-101 in 1 CARTON09/01/202012/31/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 200 mL
    Part 21 JAR 90 
    Part 31 POUCH 18 
    Part 1 of 3
    CLEARASIL RAPID RESCUE DEEP TREATMENT WASH 
    salicylic acid lotion
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-432-01200 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00612/01/2017
    Part 2 of 3
    CLEARASIL RAPID RESCUE DEEP TREATMENT PADS 
    salicylic acid cloth
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.02 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOCETETH-20 (UNII: O020065R7Z)  
    HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Product Characteristics
    Color    Score    
    ShapeROUNDSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-431-9090 in 1 JAR; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00612/05/2017
    Part 3 of 3
    CLEARASIL ULTRA OVERNIGHT SPOT 
    cleansing (cold creams, cleansing lotions, liquids, and pads) patch
    Product Information
    Route of AdministrationTOPICAL
    Product Characteristics
    shapeROUNDC48348
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    118 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic09/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00609/01/202012/31/2024
    Labeler - RB Health (US) LLC (081049410)
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